A collaborative, computer-assisted, psycho-educational intervention for depressed patients with chronic disease at primary care: protocol for a cluster randomized controlled trial

Abstract

Background Depression and chronic diseases are frequently comorbid public health problems. However, clinical guidelines often fail to consider comorbidities. This study protocol describes a cluster randomized trial (CRT) aimed to compare the effectiveness of a collaborative, computer-assisted, psycho-educational intervention versus enhanced usual care (EUC) in the treatment of depressed patients with hypertension and/or diabetes in primary care clinics (PCC) in Santiago, Chile. Methods Two-arm, single-blind, CRT carried out at two municipalities in Santiago, Chile. Eight PCC will be randomly assigned (1:1 ratio within each municipality, 4 PCC in each municipality) to the INTERVENTION or EUC. A total of 360 depressed patients, aged at least 18 years, with Patient Health Questionnaire-9 Item [PHQ-9] scores ≥15, and enrolled in the Cardiovascular Health Program at the participating PCC. Patients with alcohol/substance abuse; current treatment for depression, bipolar disorder, or psychosis; illiteracy; severe impairment; and resident in long-term care facilities, will be excluded. Patients in both arms will be invited to use the Web page of the project, which includes basic health education information. Patients in the INTERVENTION will receive eight sessions of a computer-assisted, psycho-educational intervention delivered by trained therapists, a structured telephone calls to monitor progress, and usual medical care for chronic diseases. Therapists will receive biweekly and monthly supervision by psychologist and psychiatrist, respectively. A monthly meeting will be held between the PCC team and a member of the research team to ensure continuity of care. Patients in EUC will receive depression treatment according to clinical guidelines and usual medical care for chronic diseases. Outcome assessments will be conducted at 3, 6, and 12 months after enrollment. The primary outcome will be depression improvement at 6 months, defined as ≥50% reduction in baseline PHQ-9 scores. Intention-to-treat analyses will be performed. Discussion This study will be one of the first to provide evidence for the effectiveness of a collaborative, computer-assisted, psycho-educational intervention for depressed patients with chronic disease at primary care in a Latin American country. Trial registration retrospectively registered in ClinicalTrials.gov, first posted: November 3, 2020, under identifier: NCT04613076.

Revision Sistemática Sobre Psicoterapias Efectivas Y/O Tratamientos Combinados Con Pacientes Con Severidad Y Comorbilidad

“…En esta misma línea, varios autores abordan la evidencia basada en la práctica (Gimeno Peón, 2022, Ávila Espada, 2020, Barkham et al, 2018, y cómo la práctica puede ser conside-rada evidencia. Varios autores están revisando la efectividad y eficacia de las intervenciones por Internet para distintas patologías, particularmente depresión (Kerber et al, 2021, Ontario Health, 2021, Barceló-Soler et al, 2019, Nieto, 2021, Rojas et al, 2021, Forman -Hoffman et al, 2021. Hay estudios de caso con este tipo de pacientes (Scherb, 2014), y artículos vincula-dos a la conceptualización de la psicoterapia basada en evidencias (Campbell et al, 2013) La gran mayoría de las intervenciones psicológicas provienen de la raigambre de la terapia cognitivo -conductual, aunque también se hallaron algunos artículos con base en modelos de corte psicodinámico (Camacho-Mata et al, 2015;Mingote et al, 2019).…”

The Impact of a Yoga-Based Mindfulness Intervention versus Psycho-Educational Session for Older Adults with Mild Cognitive Impairment: The Protocol of a Randomized Controlled Trial

“…The neurologist in charge of evaluation for the diagnosis of patients with MCI will keep an up-to-date record of the participants’ contact information to prevent data loss during the follow-up period. Participants who decide to withdraw from the study will no longer complete follow-up assessments [ 76 ].…”

“…After completion, these electronic forms will be submitted online through a safe platform to be automatically downloaded to a unique and encrypted database. No copies of the data will be kept on the electronic devices used in the study (e.g., smartphones, tablets, and personal computers) [ 76 ]. Data will be stored in a centralized database [ 76 ].…”

“…No copies of the data will be kept on the electronic devices used in the study (e.g., smartphones, tablets, and personal computers) [ 76 ]. Data will be stored in a centralized database [ 76 ]. Tin order to protect the confidentiality of participants, other measures will be taken.…”